Medical evidence has established that cigar and pipe smoking cause cancer of the oral cavity and that cigarette smoking is directly linked to lung cancer. Smokeless tobaccos such as chewing tobacco and snuff have also been associated with increased risks of cancer of the oral cavity. In many countries today, as many as one third of all cancer deaths can be attributed to cigarette smoking. Smoking also increases the risks of contracting diseases of the heart and lungs. This is due to the fact that tobacco smoke has a high content of hazardous particles, including nicotine, a high content of carbonmonooxid (CO) and a high content of tar, all of which seriously affect the proper functioning of both airways and lungs. It has been shown that regular smoking over a prolonged period of time leads to an increased risk of diseases of the airways, such as e.g. chronic bronchitis.
Nicotine is an alkaloid and one of many poisonous substances contained in tobacco. Nicotine is generally regarded as being addictive and generates a mild narcotic effect. Other well known alkaloids are e.g. cocaine, morphine and strychnine.
Nicotine is a serious health hazard and has a contracting effect on the vascular system as it constricts the blood vessels and leads to a raised blood pressure. These effects put a strain on the heart function. It is not known for certain if nicotine alone, or in combination with one or more of the more than four thousand different substances present in tobacco, causes the long-term health hazards associated with tobacco smoking and/or use of tobacco. "Use of tobacco" when used herein should be understood to comprise all aspects of tobacco use leading to an intake of nicotine, be it through smoking or otherwise. Consequently, the tobacco may be in the form of tobacco for use in a cigarette, a cigar, pipe tobacco, chewing tobacco, snuff and the like.
It is well known that tobacco suppresses the appetite and accordingly, many people use tobacco as an aid in weight control. As a consequence hereof, many people wishing to stop smoking often experience that a tobacco use cessation is associated with an undesirable weight gain that may easily counteract the otherwise positive effects associated with a non-smoking life-style. The conventional "anti-smoking compositions" available on the market often do not adequately take into account the undesirable effects of a weight gain associated with the unaided decision to stop smoking or the deliberate participation in a cure of nicotine dependence.
"Anti-smoking composition" in the context used above should be understood as a composition generally intended for helping an individual to stop smoking. Examples of such "anti-smoking composition" are listed on pages 822-823 of the Danish Drug Catalogue (1997). The composition may be in the form of a nicotine-releasing agent such as a nicotine-containing chewing gum or a nicotine patch. The term "anti-smoking composition" is thus used to describe nicotine-releasing agents for use by an individual in locations where smoking is prohibited as well as nicotine-releasing agents used as a substitute for nicotine-containing tobacco during a cure of nicotine dependence.
The provable connection between tobacco use and the numerous health hazards associated therewith has led many people, especially smokers, to decide quitting the habit and stop using tobacco. The statistics are very convincing: More than 80% of all smokers express a desire to stop smoking, and each year 35% try to stop smoking, but less than 5% are successful in unaided attempts to quit the habit. (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, DSM-IV.TM., 4th edition, 1995; p. 242-7).
The addiction to nicotine results in the occurrence of well known withdrawal symptoms in an individual following smoking cessation. The severity of the symptoms depends on the period of time and the amount of nicotine used. The withdrawal symptoms make it very difficult for many people to break their habit of smoking and/or using tobacco. Nicotine dependence and withdrawal will occur following use of any form of tobacco (cigarettes, cigars, pipe tobacco, snuff and the like) as well as with prescription medications (nicotine chewing gums, patches and the like). The relative ability of a tobacco to generate a dependence and/or to induce a withdrawal is associated not only with the nicotine content of the tobacco in question, but also with the route of administration. The dependence is most pronounced for smoking tobacco and a decreasing dependence is observed over the range from smoking to oral intake to transdermal administration.
Nicotine dependence is manifested by the absence of nausea, dizziness and other characteristic symptoms despite using substantial amounts of nicotine. Nicotine withdrawal associated with tobacco use cessation will often induce symptoms such as for example lack of concentration, anxiety, a dysphoric or depressed mood, anger, restlessness, frustration, insomnia, irritation, a reduced heartbeat frequency and an increased appetite, which in turn often results in a weight gain. Smoking and/or tobacco use cessation after a regular daily intake of nicotine over a period of e.g. several weeks will generate the above-mentioned symptoms. Accordingly, it is the lack of nicotine at the time following smoking cessation which leads to the above-described symptoms. (American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, DSM-IV.TM., 4th edition, 1995; p. 242-7).
Much research has shown that for many tobacco smokers and/or users, smoking cessation leads to a subsequent weight gain. In an American analysis it was furthermore shown that women generally have a tendency to gain more weight after smoking cessation than men. It was found that after smoking cessation, the women participating in the study gained an average of 3.8 kg, while the men only gained an average of 2.8 kg. (Williams D F., Madans J., Anda R F., et al. Smoking cessation and severity of weight gain in a national cohort. N. Engl.J. 1991; 324; p. 739-45).
Several commercially available products have been introduced in order to facilitate smoking cessation. Many of these products contain nicotine and release the nicotine during use of the product. Among such products are NICORETTE.RTM. chewing gum and NICORETTE.RTM. inhaler from Pharmacia & Upjohn A/S, NICOTINELL.RTM. chewing gum and nicotine patches from Ciba A/S, or NICOLAN.RTM. nicotine patches from Astra A/S.
Use of the above-mentioned products reduces some, but not all, of the withdrawal symptoms which occur in connection with smoking cessation. Although the above-mentioned products contain nicotine, which is subsequently released to the user during use, it is not unusual that the user gains weight, even when using these products. The weight gain is one major reason for many people to start smoking again. Psychological factors also seem to play a role, and may also explain the increased appetite experienced by many people after smoking cessation. It is well-known that some people following smoking cessation start to eat compulsively and often console themselves with cakes, sweets and the like.
The increased appetite and compulsive eating may well lead to a weight gain, unless the individuals dietary and/or exercising habits are not altered accordingly. On the basis of this knowledge and in expectation of an increased appetite, and possibly also compulsive eating habits, many people will try to change their diet in connection with smoking cessation and/or use of tobacco. However, it is not always easy to change ordinary eating habits and start eating dietetic food or a diet containing a low amount of calories. In fact, loosing weight is for many people a big enough problem in itself.
In some cases, the weight gain in connection with tobacco use cessation may well be so predominant that it bounces the advantages naturally associated with tobacco use cessation. Several studies have shown that a weight gain is more pronounced among women than among men. For many women a weight gain in connection with tobacco use cessation is unacceptable and causes women to take up smoking again.
More factors can explain the weight gain, such as e.g. a change in the metabolic state and turn-over, a change in the perception of desirable or preferred foods as well as psychological factors including intake of foods as a substitute for the psychological effect previously provided by tobacco smoking. Even though the change in the basal metabolic state may not be easily controlled by a subsequent change in dietary habits, some of the other factors can be controlled in order to prevent an individual from taking up smoking again. It has been attempted to combine weight control programmes and smoking cessation, but without any real success.
Applicants co-pending application PCT/IB97/00152 discloses a dietary composition on the basis of soybean ingredients. More particularly, the invention relates to a dietary composition which is useful as a weight-reducing diet for overweight or obese people or generally useful for lowering serum lipids.
The invention described in PCT/IB97/00152 is based on the observation that serum lipid concentrations in subjects having an increased serum lipid concentration were significantly lowered following the intake of the dietary composition. As an additional benefit, the composition not only lowers increased serum lipid concentrations, but also has a lipid-lowering effect in individuals having a normal serum lipid concentration.
Dietary compositions disclosed in PCT/IB97/00152 are also capable of reducing the level of total cholesterol and total triglycerides. The HDL/LDL-cholesterol ratio in serum is also improved. High serum levels of cholesterol generated by e.g. smoking cause disease and death by contributing to the formation of atherosclerotic plaques in arteries throughout the body.